← FDA DRUG APPROVALS

FDA NDA · NDA021856

ULORIC

febuxostat

Sponsor: TAKEDA PHARMS USA

APPLICATION
NDA021856
TYPE
NDA
ORIGINAL APPROVAL
2009-02-13
LATEST ACTION
2023-04-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ULORIC · ReferencePrescription
FEBUXOSTAT 80MG · TABLET · ORAL
ULORIC · ReferencePrescription
FEBUXOSTAT 40MG · TABLET · ORAL

Approval history

2023-04-17Labeling · Supplement 15 · standard — Label ↗AP
2019-02-21Efficacy · Supplement 13 · standard — Label ↗AP
2018-02-06Labeling · Supplement 12 · standard — Label ↗AP
2017-08-15Efficacy · Supplement 11 · standard — Label ↗AP
2016-02-12Manufacturing (CMC) · Supplement 9 · standardAP
2014-10-23Manufacturing (CMC) · Supplement 8 · standardAP
2013-12-12Manufacturing (CMC) · Supplement 7 · standardAP
2012-11-01Labeling · Supplement 6 · unknown — Label ↗AP
2011-01-28Labeling · Supplement 3 · unknown — Letter ↗AP
2009-02-13Type 1 - New Molecular Entity · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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